Medical device securement system and method

ABSTRACT

A medical device securement system is configured to secure medical devices such as catheters in place. The securement system includes an anchor pad that attaches to a patient&#39;s skin. A malleable support base is attached to an upper surface of the anchor pad. The support base has front and back inclined surfaces that are separated by an offset surface that extends generally normal to both of the inclined surfaces. A spot of adhesive is applied to one or more of the inclined surfaces. A catheter assembly includes a connector having a first connector portion with a diameter larger than an adjacent second structure. The catheter assembly is attached to the support base with the first connector portion engaged with and supported by the back inclined surface, and the second connector portion engaged with and supported by the front inclined surface.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/900,401, filed Feb. 20, 2018, which is a continuation of U.S.application Ser. No. 14/639,777, filed Mar. 5, 2015, now U.S. Pat. No.9,895,514, which is a continuation-in-part of U.S. application Ser. No.14/607,063, filed Jan. 27, 2015, which claims priority to U.S.Provisional Application Nos. 62/083,015, filed Nov. 21, 2014 and61/932,093, filed Jan. 27, 2014. The entirety of each of these priorityapplications is hereby incorporated by reference.

BACKGROUND

The present disclosure relates to the field of securement systems forattaching a medical device to a patient.

Medical treatments often involve relatively long term use of tubes suchas catheters to deliver fluids to or from a patient. For example,percutaneously inserted catheters are often used to deliver fluidsdirectly into the bloodstream. In such cases, the catheter extendsthrough the patient's skin and tissues and into a blood vessel. Once thecatheter is placed within the patient, it is desired to preventunintentional migration or dislodgement of the catheter. As such, thecatheter and/or a catheter hub to which it is attached are typicallyaffixed to the patient by surgical tape and/or a securement device.

Prior securement methods and devices suffer from various shortfalls. Forexample, surgical tape can provide an insecure fit, and the tape canpresent an increased risk of spreading infection. However, specializedcatheter securement devices can be excessively bulky, uncomfortable forpatients, and expensive. Further, some securement devices can only beoperated with specially-made catheter assemblies.

SUMMARY

There is a need in the art for a medical device securement system thatsecurely holds the catheter assembly so as to resist migration anddislodgement, is comfortable for the patient, is compatible withstandard catheter assemblies, and is neither unduly bulky nor expensive.

In accordance with one embodiment, the present specification describes amedical article securement device having an anchor pad and a malleable,compressible support base. The anchor pad is configured to be adhered toskin of a patient. The support base is attached to and extends upwardlyfrom the anchor pad. The support base has a first inclined upper surfaceand a second inclined upper surface that are longitudinally aligned withone another. An offset surface extends between the first and secondinclined upper surfaces, which are planar and parallel to one another. Amedical article has a first connector portion having a first diameterand a second connector portion having a second diameter. The secondconnector portion is positioned adjacent a distal end of the firstconnector portion, and the second diameter is less than the firstdiameter. The first connector portion is supported by the secondinclined upper surface and the second connector portion is supported bythe first inclined upper surface.

In accordance with another embodiment, a portion of the distal end ofthe first connector portion engages the offset surface. Another suchembodiment additionally comprises an adhesive layer disposed on aportion of the second inclined upper surface, and the second connectoris adhered to the second inclined upper surface via the adhesive layer.

Yet another embodiment additionally comprises a suture attached to thesupport pad and wrapped about one of the first and second connectorportions.

In yet another embodiment, the first inclined upper surface does nothave an adhesive layer attached thereto.

In still another embodiment, the adhesive layer is disposed on only aportion of the second inclined upper surface.

In a yet further embodiment, the adhesive layer is configured topreferentially stick to the second inclined upper surface rather thanthe second connector portion.

In a still further embodiment, the support base comprises a foam.

In still another embodiment, the support base is a monolithic piece offoam. In other embodiments, however, the support base comprises a firstportion constructed of a first material and a second portion constructedof a second material, and the first material is more malleable than thesecond material.

In accordance with another embodiment, the present specificationprovides a method, comprising applying an anchor pad of a securementdevice onto the skin of a patient, wherein the anchor pad has a supportbase extending therefrom, and the support base has a first inclinedsurface and a second inclined surface, the first and second inclinedsurfaces being parallel and joined end to end by an offset surface. Amedical device connector system is rested on the support base so that afirst connector portion is supported by the second inclined surface anda second connector portion is supported by the first inclined surface. Adistal end of the first connector portion rests against the offsetsurface. An adhesive cover is adhered onto the medical device connectorsystem.

Some such embodiments additionally comprise attaching the firstconnector portion to a glue dot arranged on the second inclined surface.

Yet another embodiment additionally comprises detaching the firstconnector portion from the second connector portion.

Still another embodiment additionally comprises detaching the firstconnector portion from the second inclined surface.

A yet further embodiment additionally comprises discarding the firstconnector portion and replacing it with a second first connectorportion, and additionally comprises attaching the second first connectorportion to the second connector portion and attaching the second firstconnector portion to the second inclined surface.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of a catheter assembly in accordancewith the present disclosure;

FIG. 2 is a perspective view of a securement device in accordance withthe present disclosure;

FIG. 3 is an exploded perspective view of the securement device of FIG.2;

FIG. 4A is a top plan view of the securement device of FIG. 2;

FIG. 4B is a side view of the securement device of FIG. 4A;

FIG. 5A is a top plan view of a support base for use with the securementdevice of FIG. 2;

FIG. 5B is a side view of the support base of FIG. 5A;

FIG. 6 is a top plan view of an anchor pad of the securement device ofFIG. 2;

FIG. 7 is a perspective view showing the catheter assembly of FIG. 1inserted into a patient and the securement device of FIG. 2 affixed tothe patient's skin;

FIG. 8 shows the assembly of FIG. 7 with the catheter assembly attachedto the securement device;

FIG. 9 shows the assembly of FIG. 8 ready for an adhesive cover memberto be placed thereon;

FIG. 10 shows the assembly of FIG. 9 with an adhesive cover memberplaced there over;

FIG. 11 is a top plan view of another embodiment of a securement devicein accordance with the present disclosure;

FIG. 12 shows the securement device of FIG. 11 with a catheter assemblyattached thereto;

FIG. 13 shows a side view of an embodiment of a support base inaccordance with the present disclosure;

FIG. 14 shows a side view of another embodiment of a support base inaccordance with the present disclosure;

FIG. 15 shows a side view of another embodiment of a securement devicehaving a catheter assembly secured thereon;

FIG. 16 is a side view of yet another embodiment of a securement devicein accordance with the present disclosure;

FIG. 17 is a side view of still another embodiment of a securementdevice in accordance with the present disclosure; and

FIG. 18 shows the securement device of FIG. 17 with a catheter assemblysecured thereto.

DESCRIPTION

The following description and the accompanying figures describe and showembodiments that serve as illustrative examples of medical devicesecurement systems and associated methods, including various inventiveaspects and features. The illustrated embodiments are made in connectionwith a catheter assembly. Illustration of the securement system in thiscontext is not intended to limit the disclosed aspects and features tothe specific embodiments or to imply that such aspects and features canbe used only with the illustrated catheter assembly. Those of skill inthe art will recognize that the disclosed aspects and features are notlimited to any particular embodiment of a securement system, andsecurement systems that include one or more of the inventive aspects andfeatures described herein can be used in connection with a variety ofmedical articles.

With initial reference to FIG. 1, a catheter assembly 30 is shown. Theillustrated catheter assembly 30 includes a catheter 31 comprising anelongated catheter tube 32 that terminates in a tapered distal tip 34. Aproximal end of the catheter tube 32 is attached to a bushing 36, whichin turn is attached to a catheter hub 40. The illustrated catheter tube32 preferably is flexible and configured for use in a standardvenipuncture procedure to provide access to a patient's blood vessel. Aproximal end of the catheter hub 40 preferably is threaded. In theillustrated embodiment, a fluid delivery line 41 comprises medicaltubing such as intravenous (IV) tubing 42 having a connector such as aLuer connector 44. The IV tubing 42 attaches to an elongated fitting 48which fits into a proximal end of the catheter hub 40. A collar or spinnut 50 slides over the elongated fitting 48 and has internal threadsthat can engage the hub's proximal threads so as to attach the fluiddelivery line 41 to the catheter 31.

With reference next to FIGS. 2-6, a catheter securement device 55 isconfigured to hold the catheter assembly 30 in place on a patient. Thesecurement device 55 comprises an anchor pad 60 having a front edge 62and a back edge 64. The front edge 62 includes a cavity 66. An axis 68extends centrally from the front to the back of the anchor pad 60. Theanchor pad 60 is configured to engage the patient's skin and hold thesecurement device 55 on the skin. As such, depending on the location ofplacement on the patient and the specific goals of the device, the shapeof the anchor pad 60 may vary in different embodiments.

The anchor pad 60 preferably has a laminate structure with an upperlayer 70 and a lower adhesive layer 72. In one preferred embodiment, theupper layer 70 comprises a woven polyester material commerciallyavailable from Tyco under the name “Tricot.” It is to be understood,however, that other embodiments may employ woven or nonwoven polymer ornon-polymer textile materials. In yet further embodiments the upperlayer may be constructed of paper or foam.

The lower adhesive layer 72 is configured to adhere the anchor pad 60 tothe skin of the patient, and can include a medical grade adhesive thatis either diaphoretic or non-diaphoretic, depending upon the particularapplication. In some embodiments the lower adhesive layer 72 may includeadditional types of medical adhesives. Also, some embodiments of thelower adhesive layer 72 may comprise anti-bacterial or anti-microbialmaterial such as a legal dynamic metal salts or oxides, or combinationsthereof. The adhesive layer 72 may be a solid layer or may be configuredas an intermittent layer such as in the pattern of spots or strips.

A removable release liner 74 preferably covers the adhesive layer 72before use. The release liner 74 may be configured as a single piece, ormay be divided into two or more adjacent pieces in order to may makeremoval easier. The release liner 74 can be made of any of severalmaterials, including paper, polymers, or combinations thereof In oneembodiment, the release liner 74 may comprise a material made of polycoated, siliconized paper, or another suitable material such as highdensity polyethylene, polypropylene, polyolefin, or silicon coatedpaper.

A catheter support base 80 is attached to the upper layer 70 of theanchor pad 60. The support base 80 preferably comprises a malleable,compressible material such as a polyethylene foam or any of severalother compressible foams. As shown, preferably the support base 80 isattached to the upper layer 70 so that a front wall 82 of the supportbase 80 is adjacent the front edge 62 of the anchor pad 60 in the cavity66, and a back wall 84 of the support base 80 is positioned adjacent theback edge 64 of the anchor pad 60. Preferably the support base 80 isaligned with the axis 68 of the anchor pad 60.

Continuing with reference to FIGS. 2-6, a front inclined surface 86extends from a front edge 87 at which it intersects the front wall 82 toa back edge 88. An offset surface 89 extends from the front inclinedsurface back edge 88, preferably at an angle substantially normal to thefront inclined surface 86. A back inclined surface 90 extends from afront edge 91 at which it intersects with the offset surface 89 to aback edge 92 at which it intersects the back wall 84. As shown, thefront and back inclined surfaces are longitudinally aligned with oneanother. Opposing side surfaces 94 extend from the front wall 82 to theback wall 84 on opposite sides of the support base 80. The opposing sidesurfaces 94 intersect the front inclined surface 86 and the backinclined surface 90 along opposing side edges 96.

With particular reference to FIG. 5B, preferably the front and backinclined surfaces 86, 90 are inclined at substantially the same angle α,and the offset surface 89 is substantially normal to both the front andback inclined surfaces 86, 90.

In the illustrated embodiment, a thickness 93 of the support base 80 atthe front edge 87 of the front inclined surface 86 is greater than athickness 95 of the support base at a front edge 91 of the back inclinedsurface 90, and a thickness 97 of the support base at the back edge 88of the first inclined surface 86 is greater than a thickness 99 of theback edge 92 of the second inclined surface 90. It is to be understood,however, that in other embodiments these relationships could be reversedor configured otherwise.

With particular reference next to FIG. 3, an adhesive layer 100preferably is applied to the support base 80. The adhesive layer 100 canbe evenly applied across the front, offset, and back inclined surfaces86, 89, 90 or can be applied over only a portion of one or more of thesurfaces. Adhesive preferably is applied to at least one of the frontand back inclined surfaces 86, 90. In the embodiment illustrated in FIG.3, the adhesive layer 100 comprises a front adhesive portion 100 aapplied to the front inclined surface 86 and a back adhesive portion 100b applied to the back inclined surface 90. The adhesive portions 100 a,100 b shown in FIG. 3 cover substantially all of their respectiveinclined surfaces 86, 90. It is to be understood that, in otherembodiments, adhesive portions may cover only a part of the respectivesurfaces.

A release liner 102 preferably is applied to the adhesive layer 100. Therelease liner 102 can be formed from various materials, as is therelease liner 74 of the anchor 60, and can have various shapes andsizes. For example in the embodiment illustrated in FIGS. 2-6, therelease liner 102 spans the front, offset, and back inclined surfaces86, 89, 90. In other embodiments, the release liner may be constructedof multiple pieces, and separate pieces of the release liner can contactseparate ones of the inclined services. In still further embodiments,adhesive may be applied to only one or the other of the front and backinclined surfaces 86, 90, and the release liner is applied only to thesurface bearing adhesive.

As noted above, the anchor pad 60 helps secure a catheter assembly 30 inplace on the patient. The clinician may use standard venipunctureprocedures to place the catheter tube 32 into a patient's vasculature,and then attach a fluid delivery line 41 to the catheter. FIG. 7 showssuch an arrangement in which the catheter tube 32 extends through apatient's skin 110 at an insertion site 112. The clinician can removethe release liner 74 from the anchor pad 60 and place the anchor pad sothat its lower adhesive layer 72 engages the patient's skin 110, and itsaxis 68 is aligned with the insertion site 112. The clinician may alsoremove the release liner 102 from the support base 80.

With reference next to FIG. 8, the clinician then can place the catheterassembly 30 onto the support base 80 so that the spin nut 50 rests uponthe back inclined surface 90 and the catheter hub 40 rests upon thefront inclined surface 86. Preferably, the bushing 36, which may have aportion with a diameter greater than the adjacent hub 40, is arrangedforwardly of the front wall 82. Due to the thickness 93 at the frontedge 87, the bushing 36 is spaced from the patient's skin 110. In theillustrated embodiment, the front adhesive portion 100 a engages the hub40 and the back adhesive portion 100 b engages the spin nut 50, holdingthe catheter assembly 30 in place on the securement member 55. Ofcourse, as discussed above, in another embodiment, only a back portion100 b of adhesive is provided. In still other embodiments, only a frontportion 100 a of adhesive is provided.

In another embodiment, one or more sutures can be applied to secure thecatheter assembly 30 to the support base 80. More specifically, theclinician may suture into the support base rather than suturing into thepatient's skin. As such, the suture would secure the catheter assemblyto the support base. In some embodiments, such a suture can be appliedin addition to adhesive placed on the front or back inclined surfaces.In additional embodiments, no adhesive, or a very weak adhesive, isapplied to one or more of the front and back inclined surfaces, and thesuture extending through the support base and tied around the catheterassembly secures the catheter assembly to the support base. In stilladditional embodiments, an adhesive can be applied to one or the otherof the front and back inclined surfaces, and a suture can be placed inthe other of the front and back inclined surfaces.

In the illustrated embodiment, the offset surface 89 approximates thedifference in diameter between the spin nut 50 and the catheter hub 40.As such, the offset surface 89 improves the fit of the catheter assembly30 on the support pad 80. Further, the offset surface 89 engages adistal end of the spin nut 50, thereby blocking the catheter assembly 30from moving distally. The adhesive layer 100 provides stable securementof the catheter assembly 30 to the support base 80, and also resistsmovement of the assembly proximally, or in any direction. The malleablesupport base 80 accommodates hard portions of the catheter assembly 30,lifting them from the patient's skin 110. Also, deformation of the foamsupport base 80 absorbs and/or spreads out force is applied by contactpoints of the catheter assembly 30. As such, the illustratedconfiguration improves patient comfort.

In one embodiment, the adhesive layer 100 may be tacky but notnecessarily tacky enough to hold the catheter assembly 30 in place onthe securement device 55 without assistance in the long-term. Withreference next to FIG. 9, in one embodiment the adhesive layer is tackyenough to hold the catheter assembly in place while the clinicianprepares to apply a cover dressing 114, which could be an adhesive-baseddressing such as a transparent dressing available from 3M under thebrand name Tegaderm™. In this embodiment, the clinician prepares thecatheter assembly by forming a loop in the IV tubing 42. The coverdressing 114 is then advanced over the catheter assembly 30, securementdevice 55, and catheter insertion point 112 as depicted in FIG. 10. Inthis embodiment, the tacky adhesive layer holds the catheter assembly 30in place long enough for the adhesive cover dressing 114 to be applied.

In the embodiment illustrated in FIGS. 7-8, the clinician secures theanchor pad 60 to the patient's skin 110 before securing the catheterassembly 30 to the support base 80. In another embodiment, the clinicianmay adhere the catheter assembly to the support base 80 prior toadhering the anchor pad 60 to the patient's skin 110. In such anembodiment, the catheter assembly 30 can be anchored to the patient'sskin 110 without substantially changing the position of the cathetertube 30 relative to the catheter insertion site 112. More specifically,the clinician will not have to adjust the position of the catheterassembly 30 to fit the placement of the securement device 55 on thepatient's skin 110.

With continued reference to FIGS. 7 and 8, and additional reference toFIG. 5B, the inclined surfaces 86, 90 preferably are inclined at anangle α selected to position the catheter assembly 30 at a desiredincident angle relative to the patient's skin 110. A variety ofdifferent angles α can be used, ranging from about 0-45°, and morepreferably from about 5-25°. For instance, to secure IV catheters, it isgenerally desirable to have an angle of incidence of the catheter tubeto the skin 110 of between about 7° and 15°, and thus α can alsopreferably be between about 7° and 15°. For arterial catheters, it isdesirable for the angle of incidence of the catheter to the skin to beabout 12.5°. Thus, in some embodiments, the incline angle α can be about12.5°. In the illustrated embodiment, in which an IV catheter is securedby the securement device, the incline angle α is about 11°.

With reference next to FIGS. 11 and 13, another embodiment of asecurement device 55 also includes an anchor pad 60 upon which a supportbase 80 is disposed. The illustrated support base 80 preferably is madeof an extruded piece of foam that has front and back walls 82, 84. Thisembodiment is similar to the embodiment described above in connectionwith FIG. 5B. The illustrated support base 80 includes a front inclinedsurface 86 and a back inclined surface 90 that are separated by anoffset surface 89 in a manner similar to as discussed above. In theillustrated embodiment, the thickness 99 of the support base 80 at theback edge 92 of the back inclined surface 90 is greater than thethickness 97 at the back edge 88 of the front inclined surface 86.However, in the illustrated embodiment, the thickness 93 of the frontedge 87 of the front inclined surface 86 is about the same as thethickness 95 of the front edge 91 of the back inclined surface 90.

Continuing with reference to FIG. 13, during manufacture, preferably anelongate foam piece is extruded having the profile of the support base.The elongated foam piece can then be cut into several support bases,which can each then be adhered to the upper surface 70 of an associatedanchor pad 60. In the illustrated embodiment, the inclined surfaces 86,90 are generally planar. In other embodiments, one or both of theinclined surfaces could be curved, such as being concave to curve aboutan axis of a catheter assembly.

With reference again to FIG. 11, in the illustrated embodiment, adhesiveis placed on only a portion of the support base 80. More specifically,as shown, a glue dot is placed generally centrally in the back inclinedsurface 90, while the front inclined surface 86 and the offset surface89, are free of adhesive. As shown, the glue dot 100 b covers less thantwo thirds, and in some embodiments about half or less, of the area ofthe second inclined surface 90. The illustrated glue dot 100 bpreferably comprises a hot melt adhesive, which is deposited on thesecond inclined surface 90 during manufacture. A release liner (notshown) can be placed atop the glue dot 100 b. Such a release liner neednot cover any more than the glue dot 100 b, and may not also be disposedover any part of the front inclined surface 86 or the offset surface 89.

It is to be understood, however, that in other embodiments the glue dotcan be placed on only the front inclined surface 86. In furtherembodiments, glue dots can be placed on both the front and back inclinedsurfaces 86, 90. Still additional embodiments may employ a glue dot onthe offset surface 89 instead of or in addition to glue dots beingplaced on one, the other, or both of the front and back inclinedsurfaces.

With additional reference to FIG. 12, in use, a clinician removes therelease liner from the second inclined surface 90 of the support base 80to expose the glue dot 100 b. The spin nut 50 of the catheter assembly30 is then placed into contact with the glue dot 100 b and the spin nut50 is pushed into the foam support base 80 in order to help establish afirm adhesive bond. As such, the catheter hub 40 rests upon the frontinclined surface 86, but without being directly adhered to the frontinclined surface 86. In an additional embodiment, a suture extendingthrough the support pad below the front inclined surface 86 can securethe catheter hub 40 to the front inclined surface without employing anadhesive. As in embodiments described above, a cover, such as anadhesive Tegaderm™ transparent dressing, can be placed over the entireassembly.

A clinician can change a dressing employing the illustrated securementdevice 55. For example, the Tegaderm™ transparent dressing can beremoved and then the spin nut 50 can be pulled off of the support base80. Preferably the glue dot 100 b is configured to preferentially stickto the foam support base 80 so that the glue dot 100 b does not stick tothe spin nut 50. The spin nut 50 can then be disconnected from thecatheter hub 40 so that the associated IV line 42 can be discarded andreplaced, while the catheter hub 40 and associated catheter tube 32 canremain in place. Since the hub 40 was never adhered to the support base80 in this embodiment, there would be no adhesive residue on the surfaceof the catheter hub 40. The securement device 55 can be peeled off ofthe patient's skin and replaced with a fresh, sterile securement device55. A new Luer connector 44 and associated IV line 42 can also beattached to the catheter hub 40. The spin nut 50 of the replacement Luerconnector 44 can then be attached via the glue dot 100 b to the backinclined surface 90 of the fresh securement device, and a fresh coverdressing 114 can then be placed over the assembly.

With reference next to FIG. 14, another embodiment of a support base 120is illustrated in which the support base is made up of two differenttypes of materials. For example, the illustrated support base 120 cancomprise a first material portion 122 and a second material portion 124.The first and second material portions can comprise different types offoams having for example different levels of malleability, or cancomprise entirely different materials. In one preferred embodiment, thefirst material portion 122 comprises a first foam, and the secondmaterial portion 124 can be a gel portion comprising a soft, tackyelastomeric gel or foam. The first foam may be less malleable than thegel, and structurally supports the gel in the second material layer 124.It is to be understood that the second material layer 124 can be used onone, the other or both of the front and back inclined surfaces 86, 90,or on the offset surface 89. In some embodiments the gel may besufficiently tacky so that no adhesive 100 is deposited on the inclinedsurface. In other embodiments, however, adhesive is deposited on one ormore of the inclined surfaces.

In yet additional embodiments, the support base may not have anundulating shape with one, two, or more inclined surfaces. For example,with reference next to FIG. 15, a support base 130 comprises a single,substantially rectangular block of foam. When the catheter assembly 30is adhered to a flat top surface of the support base 130, the spin nut50, which has a greater diameter than the catheter hub 40, may crush thefoam support base more than the hub 40 does. In another embodiment, thegreater diameter of the spin nut 50 will cause the catheter assembly 30to be held at an incline.

With reference next to FIG. 16, in another embodiment, a support base140 is made of a monolithic block of foam having a front portion 142 anda back portion 144. The support base 140 is thicker in the back portion144 than in the front portion 142, and the front and back portions areconnected by an offset 146. Since the back portion 144 is thicker thanthe front portion 142, a catheter assembly 31 adhered to the supportbase 140 will be held in an inclined arrangement.

With reference next to FIGS. 17 and 18, in yet another embodiment, asupport base 150 can be formed of two separately formed pieces of foam.In the illustrated embodiment, a front part 152 of the support piecebase 150 is formed of a first material such as a first foam having afirst malleability or softness. The back part 154 of the support base150 can be formed of a second material such as a second foam having asecond softness or malleability. In the illustrated embodiment, thefront part 152 is more malleable than the back part 154 so that when thecatheter assembly is adhered to the support base 150, the foam beneaththe catheter hub 40 crushes more easily than the foam beneath the spinnut 50, and the catheter assembly is supported in an inclined manner. Inanother embodiment, the back part 154 is more malleable than the frontpart 152, and thus more easily accepts the increased deformation fromthe spin nut 50, which has a greater diameter than the hub 40. In allsuch embodiments, the malleability of the front and back parts can beselected to best support the catheter assembly 30 at a desired angle,whether that angle is generally parallel to the anchor pad 60 or withinthe range of angles a as discussed above in connection with FIG. 5B.

With continued reference to FIG. 18, another feature is illustrated inwhich a suture 160 is drawn through the support pad 150 and around thecatheter assembly to secure the catheter assembly to the support pad150. Such a feature can, of course, be combined with any embodiment. Theillustrated embodiment shows two sutures 160, but it is to be understoodthat only one, three, or more can be used as desired. In someembodiments the suture material can be provided through the support padduring manufacturing, and included within a sterile package. In otherembodiments a clinician can manually add the suture before or aftersecuring the anchor pad 60 to a patient's skin. Preferably the suturesdoes not penetrate the patient's skin.

The embodiments described above have employed a catheter assembly with aparticular hub design and Luer connector design. It is be understood,however, that embodiments employing the principles discussed above canhave somewhat different specific structure in order to accommodatecatheters or medical devices with different applications. For example,some catheters that will have somewhat different structure but may stillemployee principles discussed herein, include central venous catheters,peripherally inserted central catheters, hemodialysis catheters, andFoley catheters. Such other types of catheters may entail differentdesigns and structure for catheter hubs and connectors. Other medicalarticles having connectors that connect the article to fluid deliverytubes may also employ securement devices exhibiting the principlesdiscussed herein including for example, surgical drainage tubes, feedingtubes, chest tubes, nasogastric tubes, rectal drains, externalventricular drains, chest tubes, or any other sort of medical lines,particularly lines with connector fittings.

The embodiments discussed above have disclosed structures withsubstantial specificity. This has provided a good context for disclosingand discussing inventive subject matter. However, it is to be understoodthat other embodiments may employ different specific structural shapesand interactions.

Although inventive subject matter has been disclosed in the context ofcertain preferred or illustrated embodiments and examples, it will beunderstood by those skilled in the art that the inventive subject matterextends beyond the specifically disclosed embodiments to otheralternative embodiments and/or uses of the invention and obviousmodifications and equivalents thereof. In addition, while a number ofvariations of the disclosed embodiments have been shown and described indetail, other modifications, which are within the scope of the inventivesubject matter, will be readily apparent to those of skill in the artbased upon this disclosure. It is also contemplated that variouscombinations or subcombinations of the specific features and aspects ofthe disclosed embodiments may be made and still fall within the scope ofthe inventive subject matter. For example, the features concerningmaterials that can be used in the support base as disclosed in theembodiments depicted in FIGS. 15-18 can also be applied to undulatingsupport base embodiments as in FIGS. 13-14, and vice versa. Accordingly,it should be understood that various features and aspects of thedisclosed embodiments can be combined with or substituted for oneanother in order to form varying modes of the disclosed inventivesubject matter. Thus, it is intended that the scope of the inventivesubject matter herein disclosed should not be limited by the particulardisclosed embodiments described above, but should be determined only bya fair reading of the claims that follow.

What is claimed is:
 1. A method of making a plurality of medical linesecurement devices, comprising: extruding an elongated base precursorhaving a profiled top surface, a bottom surface, opposing first andsecond side surfaces, and having a precursor axis, the profiled topsurface being flat along the precursor axis; cutting the base precursorin a direction transverse to the precursor axis at a plurality of spacedapart locations so as to form a plurality of support bases, each supportbase having a bottom surface, a profiled top, a first wall, a secondwall, opposing first and second side walls formed by the step ofcutting, and a base axis extending from the first wall to the secondwall; and attaching the bottom surface of each support base to a topsurface of a different one of a plurality of anchor pads so that theprofiled top of each support base is spaced from the top surface of thecorresponding anchor pad.
 2. The method of claim 1, wherein, for eachsupport base that is attached to a corresponding anchor pad, the firstand second side walls extend upwardly from the corresponding anchor padand terminate upon intersecting the profiled top of the support base. 3.The method of claim 1, wherein the profiled top of the base precursorcomprises a first profiled surface, a second profiled surface and aprofiled offset surface between the first and second profiled surfaces,the first and second profiled surfaces each being flat in a directionparallel to the precursor axis.
 4. The method of claim 3, wherein theprofiled top of each support base comprises a first top surface, asecond top surface, and an offset surface between the first and secondtop surfaces, and additionally comprising applying an adhesive layer tothe second top surface.
 5. The method of claim 4, wherein a second widthis defined across the second top surface between the first and secondopposing side walls, the adhesive layer having an adhesive width lessthan the second width.
 6. The method of claim 5, wherein no adhesive isapplied to the first top surface.
 7. The method of claim 5, wherein thesecond width is greater than a diameter of a luer connector spin nut. 8.The method of claim 4, wherein the step of cutting the base precursorcomprises making a plurality of spaced apart cuts that are normal to theprecursor axis, and each base axis is parallel to the first and secondside walls.
 9. The method of claim 3, wherein the first profiled surfaceconnects to the offset profiled surface, which connects to the secondprofiled surface to define a contiguous top profiled surface.
 10. Themethod of claim 3, wherein the first profiled surface is planar andinclined, and the second profiled surface is planar and inclined, thefirst profiled surface is parallel to the second profiled surface, andthe offset profiled surface is normal to the first and second profiledsurfaces.
 11. The method of claim 10, wherein no portion of the baseprecursor extends upwardly from the first profiled surface, and whereinthe offset profiled surface extends upwardly from the second profiledsurface, but no other portion of the base precursor extends upwardlyfrom the second profiled surface.
 12. The method of claim 11,additionally comprising, for each support base that is attached to acorresponding anchor pad, providing an adhesive cover sized to cover theentire corresponding anchor pad and support base.
 13. A method of makinga plurality of medical line securement devices, comprising: extruding anelongated base precursor having a profiled top, a bottom surface,opposing first and second side surfaces, and having a precursor axis,the profiled top surface being flat along the precursor axis; cuttingthe base precursor in a direction transverse to the precursor axis at aplurality of spaced apart locations so as to form a plurality of supportbases, each support base having a bottom surface, a profiled top, afirst wall, a second wall, opposing first and second side walls formedby the step of cutting, and a base axis extending from the first wall tothe second wall; and placing each support base within a sterile package.14. A method of making a plurality of medical line securement devices,comprising: extruding an elongated base precursor having a profiled top,a bottom surface, opposing first and second side surfaces, and having aprecursor axis, the profiled top surface being flat along the precursoraxis; and cutting the base precursor in a direction transverse to theprecursor axis at a plurality of spaced apart locations so as to form aplurality of support bases, each support base having a bottom surface, aprofiled top, a first wall, a second wall, opposing first and secondside walls formed by the step of cutting, and a base axis extending fromthe first wall to the second wall; wherein the profiled top of the baseprecursor comprises a first profiled surface, a second profiled surfaceand a profiled offset surface between the first and second profiledsurfaces, the first and second profiled surfaces each being flat in adirection parallel to the precursor axis; and wherein the profiled topof each support base comprises a first top surface, a second topsurface, and an offset surface between the first and second topsurfaces, and additionally comprising applying an adhesive layer to thesecond top surface.
 15. The method of claim 14, wherein no portion ofthe base precursor extends upwardly from the first profiled surface. 16.The method of claim 15, wherein the offset profiled surface extendsupwardly from the second profiled surface, but no other portion of thebase precursor extends upwardly from the second profiled surface. 17.The method of claim 14, additionally comprising applying a removablerelease liner atop the adhesive layer.
 18. The method of claim 16,wherein the profiled top of each support base consists only of the firsttop surface, second top surface, and offset surface.
 19. The method ofclaim 16, additionally comprising placing each support base within asterile package.
 20. The method of claim 3, wherein the profiled top ofeach support base comprises a first top surface, a second top surface,and an offset surface between and intersecting both the first and secondtop surfaces, wherein the first top surface intersects the first walland the second top surface intersects the second wall.
 21. The method ofclaim 19, additionally comprising applying an adhesive layer to thesecond top surface and applying a removable release liner atop theadhesive layer.
 22. The method of claim 20, additionally comprisingplacing each support base within a sterile package.
 23. The method ofclaim 1, wherein a bottom surface of each anchor pad comprises a bottomadhesive layer configured to adhere the anchor pad to the skin of ahuman patient.
 24. The method of claim 13, wherein the profiled top ofeach support base comprises a first top surface, a second top surface,and an offset surface between and intersecting both the first and secondtop surfaces, and wherein the first top surface intersects the firstwall and the second top surface intersects the second wall.
 25. Themethod of claim 24, additionally comprising attaching the bottom surfaceof each support base to a top surface of a different one of a pluralityof anchor pads, wherein each of the plurality of anchor pads comprises abottom surface comprising a bottom adhesive layer configured to adherethe anchor pad to the skin of a human patient.
 26. The method of claim24, additionally comprising applying an adhesive layer to the second topsurface but not the first top surface, and applying a release liner atopthe adhesive layer.